A regulated plant is built once and audited for the rest of its life. Below is the sequence we work through with our clients: twenty stages from first requirements to a qualified, released facility, and the service line accountable at each one.
Stage 01 / 20 · Definition
Before geometry there is intent. We capture what the facility must make, at what scale, to which market's regulations, and test whether the business case survives contact with GMP reality. The URS written here is the document every later qualification protocol traces back to.
Stage 02 / 20 · Definition
A site is chosen on constraints, not on price alone. Utility headroom, effluent capacity, floor-to-underside height, floor loading, road access for module delivery, and room to expand later all get assessed before commitment. A cheap site that cannot take a 4 m ceiling void is not cheap.
Stage 03 / 20 · Definition
Room adjacencies fix personnel and material flow, and flow is what an inspector reads first. We set the classified envelope, the airlock positions, and the pressure cascade, then agree the regulatory strategy that the whole design will be defended against.
Stage 04 / 20 · Design
Concept becomes a buildable, defensible package: dimensioned layouts, HVAC zoning, utility schematics, and equipment schedules. Design qualification documents that the design meets the URS. Done properly here, it removes most of the findings that would otherwise surface during OQ.
Stage 05 / 20 · Design
Cleanroom panels, AHUs, and filling equipment carry lead times measured in months, so procurement starts while design details are still closing. Vendor bids are evaluated technically rather than commercially, and footprints are reserved on the drawing before an order is placed.
Stage 06 / 20 · Construction
Foundations, structural frame, roof, and envelope. The shell has to deliver the clear internal height the ceiling void needs and the floor loading the equipment demands. Both are effectively unfixable afterwards, which is why they are verified against the design before the frame closes.
Stage 07 / 20 · Construction
The slab is finished with seamless epoxy or welded vinyl, coved up the wall so there is no square internal corner anywhere a particle can sit. Falls to drain, load ratings, and equipment plinths are set now. Retrofitting them means breaking a qualified room open.
Stage 08 / 20 · Construction
Modular GMP panel systems go up on the layout grid: flush-finished, non-shedding, with coved junctions at floor and ceiling. Panel joints are sealed and every service penetration is detailed before it is cut, because each one is a future leak on the room integrity test.
Stage 09 / 20 · Construction
Double-glazed vision panels sit flush with the panel face on both sides, with no ledge, no reveal, and nothing to clean around. Sightlines let supervisors see a process without gowning into it, and door interlocks are wired so an airlock cannot be opened at both ends at once.
Stage 10 / 20 · Construction
Each room is assigned its ISO 14644 class and its place in the pressure cascade, typically 10 to 15 Pa between adjacent grades, stepping down from the cleanest space outward. Gowning and material airlocks become the only routes across a classification boundary.
Stage 11 / 20 · Systems
Supply and return runs are routed above the corridor and branched to each room, sized for the air change rate that room's class demands. Ductwork is cleaned, capped, and pressure-tested to a declared leakage class before anything is closed in. That is the last moment at which a fault is cheap to find.
Stage 12 / 20 · Systems
The air handling unit is the room's lungs and its single largest running cost. Pre-filtration, cooling, reheat, and humidity control are staged in sequence, then tied to controls so temperature, humidity, and differential pressure are trended continuously rather than spot-checked.
Stage 13 / 20 · Systems
Purified water, WFI, clean steam, compressed air, and process gases are distributed on sloped, drainable, dead-leg-free loops in sanitary stainless. Utility quality is a product quality attribute, so these systems carry their own qualification and ongoing monitoring programmes.
Stage 14 / 20 · Systems
Power distribution, emergency lighting, and containment are installed alongside the building management and environmental monitoring systems. The EMS is what proves the room stayed in a state of control between qualifications, so its sensor placement is a GMP decision, not an electrical one.
Stage 15 / 20 · Systems
A walkable ceiling closes the envelope and gives maintenance access from above, so filter changes never require entry into a classified room. Terminal HEPA housings are set on the grid, gel-sealed, then tested in place. The ceiling is where the room's cleanliness is finally made real.
Stage 16 / 20 · Equipment
Dispensing, granulation, compression, and coating equipment is set, levelled, connected to utilities, and run through site acceptance testing. Installation is documented to the standard IQ will demand, because re-creating that evidence later is far more expensive than capturing it now.
Stage 17 / 20 · Equipment
Filling, capping, labeling, and case packing arrive as separate machines and have to leave as one line. We integrate vision inspection and serialization for track-and-trace, then tune changeover so the line speed on the quotation is the line speed on the floor.
Stage 18 / 20 · Qualification
Systems are started, balanced, and proven to work before any qualification protocol is executed. Air balancing, cascade verification, control loop tuning, and punch-list closure happen here. Commissioning finds the engineering faults so that qualification can be about evidence rather than troubleshooting.
Stage 19 / 20 · Qualification
Installation, operational, and performance qualification are executed against pre-approved protocols. Cleanroom classification is certified at rest and in operation, computer systems are validated for data integrity, and cleaning and process validation demonstrate the plant makes product reproducibly.
Stage 20 / 20 · Qualification
Nothing is handed over until it is proven. The turnover package (drawings, protocols, deviations, SOPs, training records, maintenance schedules) is closed out and the quality system is live, so the facility can be inspected on day one rather than month six.
Tell us what you're building, expanding, or trying to get audit-ready. We'll respond with next steps, not a sales script.
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